Posts Tagged ‘21 CFR Part 11’

  We’ve been getting a lot of requests, lately, to help companies decommission their old GxP systems. The systems were once validated and still contain GxP data that might someday need to be reviewed or analyzed, but they’re no longer being actively used. They’re just sitting there, taking up server space, undergoing basic IT maintenance, […]

  On December 17, 2015, the FDA issued a warning letter to Sun Pharmaceuticals Industries Ltd. in Gujarat, India. Sun Pharma’s website boasts that it is the “World’s 5th Largest Specialty Generic Pharmaceutical Company” with over 2,000 products in more than 150 markets across the globe. When an organization that large winds up with a […]

  Welcome to the New Year! Similar to the way we share our most popular blog posts on a monthly basis, it only makes sense to look back at the most viewed posts from 2015. So, here it goes, with number one being the most read piece. 

  We recently discussed how Oracle’s safety system has the ability to produce ad hoc descriptive statistical reports on quality data. This brings us to the last rule we’ll discuss in our “Argus Safety for CAPAs” blog series. 

  Over time, the concept of Quality Control has evolved to become Total Quality Management (TQM). According to Wikipedia, the concept of TQM “…consists of organization-wide efforts to install and make a permanent climate in which an organization continuously improves its ability to deliver high-quality products and services to customers.” Since a CAPA system is […]

  Over the past few months, the life sciences practice has produced several free resources related to the 21 CFR Part 11 regulation that governs electronic records and electronic signatures. To make it easy for our industry colleagues to find those resources, we decided to create a single blog post that links to all of […]

  Several months ago we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Regarding “the organization” that needs to inform the FDA of the intended use of electronic signatures, in a CRO/Sponsor relationship, who is responsible: the […]

  Last November, I wrote about the new release of Oracle Clinical, Remote Data Capture (RDC), and Thesaurus Management System (TMS), version 5.1. As many companies continue to run these “tried-and-true” clinical data management and EDC systems, the enhancements were quite welcome. Since then, our data management team has been developing a complete Validation Suite […]

  Most of us “regular people” refer to pharmaceutical products by their trade name, but that’s not the case among life sciences professionals in research and development departments. In fact, during a product’s lifecycle, chances are it has been referred to by at least four names: a chemical compound, a company code, a generic name, […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: In one of the initial slides, you mentioned that documents attached to emails do not fall under 21 CFR Part 11. Could […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Does 21 CFR 11 apply to a CTMS (clinical trial management system), CDMS (clinical data management system), EMR (electronic medical record), or […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Regarding user accounts: During the User Acceptance Testing (UAT) of a system, are these accounts regulated the same way or can ‘generic’ […]